FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

FDA 510(k) Search

K Number

Device Name

MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175

Manufacturer

Date Cleared

2001-02-12

(61 days)

Product Code

MVO,DIO,DJG,DKZ,LAF,LDJ

Regulation Number

N/A

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

Intended Use

Device Description

AI/ML Overview

Summary

Regulation Number and Section

N/A